QA Ops Specialist Weekends Marietta PA

Job description

Details:
Why GSK? Because GSK's vaccines business puts the customer at the heart of everything we do. That's why we define our vaccines mission as: Protecting • Human • Kind. Protecting because we strive to turn the science of immunology into high-quality, practical protection against disease; Human because we are investing time in understanding and delivering on our customers' needs and helping them achieve their vaccination goals; and Kind because we recognize and act on our responsibilities to serve societies, rich and poor.

As the QA Operations Specialist, you will provide a link between operations and the various quality systems. The primary responsibility is to directly support Operations through real-time, on-line batch record QA review and approval. Responsibilities include:

• Perform technical review of cGMP documentation for completeness and compliance to cGMPs as outlined by governmental regulations and internal procedures.
• Provide advice and counsel on cGMP and related quality assurance issues to the value stream
• Demonstrate sound decision making relating to quality issues
• Provide on the floor QA support and perform QA Operations activities (batch record review and issuance, room release, logbook and documentation review, aseptic processing oversight, etc)
• Perform technical review of cGMP documentation for completeness and compliance to cGMPs as outlined by governmental regulations and internal procedures.
• Take initiative and follow-up with quality documentation concerns (e.g., investigations, deviations, change controls, and other required documentation).
• Perform review and support regarding discrepancies and/or anomalies noted during QA review of associated processes. This includes deviation investigations, customer complaint investigations, et al.
• Alert management of production trends which may serve as forewarning of process or equipment problems. As necessary, initiate investigations to address these issues.
• Write and/or revise controlled documents in support of job responsibilities.
• Routinely communicate and report deviations from procedures/processes to Quality Assurance Management and initiate appropriate action as necessary.

*LI-GSK

Contact information:
You may apply for this position online by selecting the Apply now button.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or (outside US).

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Desired profile

Basic qualifications:
Bachelors Degree
minimum 3 years experience in QA pharma
Or minimum 3 years experience as a manufacturing technician in an aseptic environment.
Must be able to work weekend shift (Th, Fri 7-3:30, Sat Sun 7-7:30 )

Preferred qualifications:
Working knowledge of pharmaceutical facilities, equipment and systems. Including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities.
• Training and work experience in root cause analysis tools (Isikawa) and statistical analysis (TQM, SAS) required.
• Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance. Working knowledge of validation principles, aseptic processing, quality systems and FDA regulations.
• The ability to clearly write QA documentation as necessitated by regulatory agencies and internal policies.